Phase 2
N=58
Lutropin Alfa in Women at Risk of Poor Response
Ovarian Stimulation
Bottom Line
View on ClinicalTrials.gov: NCT01112358 ↗Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Number of Oocytes Retrieved — 4.0; 3.5 Oocytes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- r-FSH (Drug); r-hLH (Drug); Analogous GnRH antagonist (Drug); r-hCG (Drug); Progesterone (Drug)
- Age
- Pediatric, Adult
- Sex
- Female
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Primary completion
- Jan 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Oocytes Retrieved |
4.0; 3.5 | — |
| PRIMARY Number of Follicles Greater Than (>) 14 Millimeter (mm) in Diameter |
7.2; 7.0 | — |
| PRIMARY Oocytes Recovery Rate |
0.56; 0.50 | — |
| SECONDARY Oocyte Nuclear Maturity Rate |
0.73; 0.61 | — |
| SECONDARY Fertilization Rate |
0.70; 0.64 | — |
| SECONDARY Number of Embryos by Quality |
0.6; 0.8; 1.4; 0.7; 1.8; 0.6 | — |
| SECONDARY Number of Embryos Transferred by In Vitro Fertilization (IVF) |
2.0; 1.6 | — |
| SECONDARY Number of Participants With Positive Pregnancy Test |
3; 5 | — |
| SECONDARY Number of Participants With Clinical Pregnancy |
3; 5 | — |
| SECONDARY Implementation Rate |
0.15; 0.14 | — |
| SECONDARY Plasma Level of Estradiol |
1218; 1029 | — |
| SECONDARY Endometrial Thickness |
12.3; 11.2 | — |
| SECONDARY Duration of Ovarian Stimulation |
4.8; 4.8 | — |
| SECONDARY rFSH Cumulative Dose |
4338; 4298 | — |
| SECONDARY Plasma Levels of LH |
2.8; 2.1 | — |
| SECONDARY Number of Participants in Whom At Least 1 Stimulation Cycle Was Cancelled |
8; 8 | — |
Summary
Evaluate the effectiveness of adding lutropin alfa (recombinant human luteinizing hormone [r-hLH]) in the middle of the follicular phase compared to no addition, in infertile women at risk of poor response stimulated with follitropin alfa (recombinant Follicle-Stimulating Hormone [r-FSH]) under Gonadotropin Releasing Hormone (GnRH) antagonist in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI), in the number and quality of oocytes, follicular development, fertilization oocyte, embryo quality, and pregnancy rate.
Eligibility Criteria
Inclusion Criteria
- Participants who were at risk of poor response by at least one of the following criteria: a) 8.5 milli IU/L
- Participants with normal baseline luteinizing hormone and E2 levels
- Regular menstrual cycles of 25-35 days
- Presence of both ovaries and uterus able to withstand pregnancy
Exclusion Criteria
- Participants who had any clinically significant disease including known human immunodeficiency virus (HIV), hepatitis-B virus (HBV)/hepatitis-C virus (HCV) positivity
- Participants with more than 3 previous assisted reproductive techniques (ART) cycles
- Participants with polycystic ovaries or cyst of unknown etiology; unexplained gynecological bleeding
- Participants who had any contraindication to being pregnant
- Active substance abuse
- Participants who had simultaneously participated in another clinical drug trial
Data sourced from ClinicalTrials.gov (NCT01112358). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.